Pressure Garment Designs for Arm Function and Quality of Life After Stroke
Compares different pressure garment designs on arm function in people after stroke.
Key facts
- Who runs it
- National University of Malaysia
- Where
- Weifang, ChinaSee the 3 sites
- Trial code
- Registry title
- Effects of Different Pressure Garments on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke
- Status
- Recruiting
- People taking part
- 165 people, planned
- Started
- 8 Oct 2024
- Planned end
- Aug 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure Garment
- Single-Layered 10% Circumferential Reduction (S-10) Pressure Garment
- Single-Layered No Circumferential Reduction (S-0) Pressure Garment
- Record updated
- 27 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who had a first stroke 1 to 12 months ago and have weakness on one side. It compares three types of pressure garment for the arm.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- First ischemic or hemorrhagic stroke within the last 1 to 12 months, with weakness of one limb at Brunnstrom stage 3, 4 or 5. Muscle tone of the elbow, wrist and hand must score 2 or less on the Modified Ashworth Scale.
Main reasons for not taking part
- Serious heart or lung disease
- Skin lesions, infections or other skin problems
- Serious circulation problems such as deep vein thrombosis
- Allergy or significant discomfort to pressure garment materials
- Arm fractures or severe joint problems
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Between 18 and 80 years of age
- Within 1-12 months of ischemic or hemorrhagic stroke
- First onset resulting in hemiparesis of a limb with Burnnstrom stage of 3, 4 or 5
- Modified Ashworth Scale with scores of less than or equal 2 for elbow, wrist, and hand muscle tone in the affected upper extremity
- Able to understand instruction
Who cannot take part
- Serious cardiovascular or respiratory diseases
- Skin lesions, infections or other skin problems
- Serious circulatory problems such as deep vein thrombosis
- Allergies or significant discomfort to pressure garment materials
- Severe cognitive impairment with Saint Louis University Mental Status (SLUMs) scores equal to or less than 27 (above high school level of education)/25 (below high school level of education)
- Upper extremity fractures or severe joint problems
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- The Affiliated Hospital of Shandong Second Medical UniversityWeifang, ChinaContact: Kuicheng Li, MOTTaking people
- Weifang Hospital of traditional Chinese MedicineWeifang, ChinaContact: Kuicheng Li, MOTTaking people
- Weifang Municipal Peoples HospitalWeifang, ChinaContact: Kuicheng Li, MOTTaking people
About the trial
What the trial wants to find out
The study aims to compare the effects of dorsal-double-layered 10% circumferential reduction (DD-10), single-layered 10% circumferential reduction (S-10), and single-layered no circumferential reduction (S-0) pressure garments on sensorimotor functions, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function, and quality of life among stroke patients during the 8 weeks of application (Time 1: Baseline, Time 2: Week 4, Time 3: Week 8).
The 3 groups in the trial
- Dorsal-Double-Layered 10% Circumferential Reduction (DD-10) Pressure GarmentTreatment being tested
A custom-fabricated finger-to-above-elbow (long glove) pressure garment with 10% of stress. The design is similar to S-10 except it has an extra layer of fabric on the dorsal aspect that gives stronger compression
- Single-Layered 10% Circumferential Reduction (S-10) Pressure GarmentExisting treatment, for comparison
A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 10% of stress.
- Single-Layered No Circumferential Reduction (S-0) Pressure GarmentPlacebo, for comparison
A custom-fabricated single-layered finger-to-above-elbow (long glove) pressure garment with 0% of stress
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Pressure Garments of Varying Designs on Upper Extremity Sensorimotor Functions and Quality of Life After Stroke: A Multicenter, Double-Blind, Prospective Randomized Controlled Trial
- Plain-language title
- Pressure Garment Designs for Arm Function and Quality of Life After StrokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06587308, who can take part
- Record updated
- 27 November 2024